How to build a quality culture in startups. Panel discussion with 5 quality experts.

 

 

To be truly successful, quality must go beyond just meeting compliance requirements. When quality is a core practice at a company, everyone from the end patient to the investors benefit. 

A Harvard study on quality found that a “company with a highly developed culture of quality spends, on average, $350 million less annually fixing mistakes than a company with a poorly developed one.” 

In this episode 5 quality management experts who work closely with entrepreneurs and startups discuss how to define a quality culture at your company and help everyone on your team strive to improve it. 

Guest in the discussion are:

  • Meg Sinclair, Sr. Quality Specialist at Qualio
  • Laura Araujo, VP of Quality at 4G Clinical
  • Kelly Stanton, Dir. of Quality at Qualio
  • Devon Campbell, Founder of Prodct LLC
  • Christie Johnson, Founder of Kasota Engineering LLC (recently joined Product)

The content for this episode comes from a webinar about quality culture. A link to the full webinar can be found below.

Show Notes: 

The Quality Culture Playbook: How to build a quality culture (full webinar)

Prodct LLC

4G Clinical

Application to be on the show: From Lab to Launch

Qualio


Music by keldez

Transcript

Transcript is automatically generated. Please kindly excuse any grammatical and spelling errors.   

Hi, everyone. Welcome to another episode of from lab to launch. Really glad you're here. We recently had a conversation with some friends who are quality experts and work closely with entrepreneurs and startups. We hosted a panel discussion about how to build a quality culture. And the discussion was just really great and applicable to anybody launching a life science product or a company today. So to get the full conversation, you can go to our resources page at quality.com or click the link in the show notes. But I wanted to take a segment of that conversation and share it with you. You'll hear from five people, Meg Sinclair. Who's a senior quality specialist at Qualio. Laura Araujo Who's a vice president of quality at 4g clinical Kelly Stanton. Who's the director of quality at Qualio. Devin Campbell. Who's the founder of Prodct, LLC and Christie Johnson who's the founder of Kasota engineering and recently joined Devin at Prodct. They talk about practical ways leaders can encourage feedback to improve quality throughout the entire organization. How it can be dangerous to limit quality mindset for the sake of just regulatory and compliance and communication tools that you can use, how to encourage ownership to everyone from front end manufacturers and people putting labeling on to senior management. Another great point. that's brought up as about engineers and founders, how they can consider documenting and taking credit for quality early on, especially preventative actions. And getting into the habit of writing those kinds of things down earlier can actually accelerate time to market and innovation. There's a fun conversation about can quality and innovation exist in the same sentence. and it absolutely candidate give some practical examples of that too. So it was a little bit longer format than what we've done in these episodes typically, but I think you're really find the discussion useful. So let's get to it.

Meg Sinclair: 

So let's go ahead and talk about what a healthy quality culture looks like. Devon, do you want to kick it off

Devon Campbell: 

I mean I think it's one where there's a lot of ownership it's one where we don't have a lot of finger pointing where we're saying that's not my responsibility. That's somebody else's responsibility to do it. A healthy quality culture. The team is there to work with each other and to drive innovation, drive quality drive best in class things. Drive, risk-based thinking throughout the entire product development and commercialization processes rather than saying that's not my job. Somebody else is going to do that. Somebody else has to think about risk. So I think a very healthy quality culture is, we're all stepping up to that plate and thinking through those aspects the, the bare core fundamentals that quality is built.

Meg Sinclair: 

Great. I think that's some great insight, Christie, anything you want to share on what a healthy quality culture looks like for you? I

Christie Johnson: 

think just to add onto what Devon was saying I think you can implement a culture of quality early people can start to think of it as a way to take credit for really, for the good work they're doing. An example would be. Thoroughly documenting testing early on. What revision of a bill of materials goes into testing. That kind of a thing, a lot of times, people just want to fly through, but really to integrate a culture of quality early means let's just take a brief moment to take credit for the great work and innovation that we're doing to write it down in a way that we all know.

Meg Sinclair: 

Laura, anything you want to add on as to healthy

Laura Araujo: 

quality culture? Yeah. So it's interesting in this heavily regulated environment that I work in, A healthy quality culture is one where quality isn't seen as the police officers or the people that are, auditing and checking boxes and making sure you adhere to regulations, right? It's where quality becomes the teachers and the helpers. And if you think about a healthy quality culture, it's really three things. Teamwork, trust and communication. And the quality organization, as in like people that report to me help facilitate those, not to police against them. So yeah,

Meg Sinclair: 

that's how we see. Yeah. I think that's an important thing. That quality is a helper and not a authority figure it's really to collaborate and work together with the team. I think another important thing to talk about here too. The quality management system that supports that culture should be usable and be something that's not only to meet requirements, but also that the business can use as readable for everyone and that they can drive. Is it going to drive this continuous improvement? So are those procedures, although its policies, are they going to help drive that improvement that the organizations looking to grow? So I think that's an important foundation.

Laura Araujo: 

It has to be helpful or, it won't work.

Devon Campbell: 

Right Nice point there, Meg like quality for the sake of, for regulatory sake. It's the wrong reason to be engaged in quality. Maybe if you're doing it just because you think regulators say you need to do things in a certain way, that's the wrong mentality. A healthy quality culture is not doing it just because. You have to do it to satisfies particular regulations. You need to do it because it's the right thing for the business and the right thing for patients. I wanted to add one other idea to look at a healthy quality culture. And this comes from, my personal practice. I work with a lot of emerging entrepreneurs and early stage companies. And I think for them a very healthy quality culture is one that is growing and evolving. And it's humble. So it starts out small. It doesn't have to be everything that you need that you think you need at the end of satisfy. Regulators is what you need and you stop and it's continuous improvement. You stop and you look at yourself and say, okay what aspects of quality should we now adopt and bring in? And how is our quality culture thriving? Are we ready to take on more pieces of it? So I think another aspect of a really healthy quality culture is one that looks at itself and grows. It's not just a static. Type system.

Meg Sinclair: 

Kelly, anything to add there on healthy quality culture.

Kelly Stanton: 

No, I think I, I think everybody's pretty well hit the mark, but I'll just add, having it be easy, accessible, making sure people understand how their roles contribute to that. Why it's important. You're not just writing this down because the quality police expect you to. Um uh you know All of those things contribute to a healthy quality culture. And to Christie's point the earlier you can embed this in your organization, the better off you are because to try to Institute it later, when people are very set in their ways can be a real uphill battle. And it's important to, for everybody to understand, we're all trying to do the right thing for the patient. And and this is part of how we do that.

Meg Sinclair: 

That's a wonderful insights about what a healthy quality culture looks like. Let's talk a little bit now about why it's important to have that healthy quality culture. It's really going to help set the organizational mindset. Are you going to be proactive or reactive against that uphill battle of, are you going to. Start with quality, or are you going to have to bring that in later when people, as Kelly said are set in their ways, and then there's also that business impact quality culture is going to help drive customer satisfaction, employee satisfaction, and ultimately the bottom line it's going to help improve efficiencies. So will really help that bottom line in the end. And then it'll help with benchmarking when you have a quality framework and that quality culture you can resource execute and evaluate your progress along the way. Aside from just feeding the requirements. Um What else do you think is the real benefit of having a quality culture panelists?

Devon Campbell: 

I'll jump in when you are trying to attract partners, whether it's, if you're a small company you're trying to attract VC money or in. Or potential strategic partners, or if you're a bigger company you're trying to attract partners to work with you having a quality culture. One of my roles in a prior prior life with a major pharmaceutical company was to go in and help do the due diligence work to look at companies. And one of the things that I would come back with when we're looking at companies to either partner with, or to buy was, do they really, truly have that kind of quality culture built in right. When you talk with, when you talk with the teams and you want, and you, it Reeves clearly through that, they all on really understand the role of quality and that they all have a responsibility to it. And it seems really clear and pervasive to the organization that shows really well. When we go back in and say, do we want to be associated with this team in some way? And to be able to say, yeah, they've got a strong quality culture. It gives you the sense of confidence that they can deliver on what they say they're going to deliver and that they can do it the right way and we can trust them.

Laura Araujo: 

Devin that extends to attracting employees too, being a growing company, it's really important for us to attract and retain, the best and really having a quality culture where every employee is empowered to make decisions. And there's clear communication. A job responsibilities is really key for that.

Meg Sinclair: 

Yeah. And I just want to piggyback onto that, Laura. I think it's really important to encourage feedback across employees. And when you're in an employee who feels empowered to give feedback and feel like you own those quality pieces, I think that just adds to the collaboration and just makes for a really great place to work when there is a quality culture in place. Anything else to share on the benefits of having a quality culture?

Laura Araujo: 

Just one clarification point, Meg is that this has to come from the top, you know that might seem obvious to people. It's not always clear and it's really easy to let the business side of things get in the way. We have shareholders, we have. Give, whoever that we have to make happy and, making the sale sometimes puts a lot of pressure on people, but, having those open conversations and really keeping a focus on quality on our patients, on, what the end goal is makes a huge difference.

Meg Sinclair: 

It's no mistake. Those ISO standards highlight top management's responsibilities. So as owners quality, so great points there, Laura. Thank you, all right. So let's go ahead and talk now about the elements behind that communication and maintaining a quality culture. So the first one being communicating quality, you got to set expectations for everyone, right? And no, Is needed setting those it's going to help everyone understand the quality policy and their quality objectives and communicating quality behaviors are tied to outcomes. So team panelists here, how can we communicate a person's job tasks fit large into that larger quality picture? If it's a frontline manufacturing worker person, just applying a label, how do we tie those roles? To that larger quality picture within the organization. What tips and tricks do you guys have to share? I'll start

Christie Johnson: 

us out mega I think from the beginning when maybe you have a new employee that is starting in a role to explain not just their quality, the quality expectations for that person, because. Of the policy or the procedure that's in place, but also to explain what is the outcome to the patient or to the safety or efficacy of the device. If we don't do certain things that we say we're going to do. So I think like explaining the bigger picture, it can be really a valuable way to communicate

Kelly Stanton: 

that.

Meg Sinclair: 

Yeah. I had a teammate this morning share. Yeah. Patients come and talk about the products they received from their manufacturer, and that had to title lasting impact on her and the work that she did. So I think that's a great way to, to tie people's work back to that end and the outcomes that we're hoping for. But these are products going into real life people. It could be your family members, your friends. So just keeping that at the forefront of their minds, as they're doing their work.

Kelly Stanton: 

Yeah, that's exactly what I was going to jump in with too. It's so important. Because it can be pretty did the job can get boring when you're working third shift manufacturing and you're just gluing parts together all day long, or all night long in this case, to make sure that they understand. You know that the country, the contribution of everyone in the organization and how that all ties together. That's definitely a very critical aspect. And even in the startup space, you've generally got people who are, very enthusiastic about the products that they have invented. But they also need to understand that, the FDA, isn't just going to take your word for it. You got to write this stuff down and you have to write it down in a way. That makes that data, that keeps the data integrity and all those kinds of things. So it definitely translates all the way, from startups to, the 60,000 employee Novartis's of the world. All of these things are important along the way, and it comes all the way down to each individual, understanding the impact of their job on the organization.

Meg Sinclair: 

And then another challenge is keeping leaders engaged. When they get removed from the front lines of quality. Laura, do you have any thoughts or suggestions on how to keep leaders engaged in college?

Laura Araujo: 

Yeah. This is where communication really comes in. And it's really important. We do a whole bunch of things as a company, which is really cool. We did implement quality right from the start. We're very lucky because we're a young company I'm only six years old at this point. But we do things like bring everyone together and we hold what we call science fairs, where everybody rotates through a small group of people that present on what they're doing, what their latest challenges are, what technology they're using. And everybody goes through it, senior management to, the office managers, so we do a lot of things like that. A lot of sharing, a lot of communications. We use a lot of tools internally as well. One of my greatest things to watch is we use like an instant message or tool and internally, and we have channels where you can post stuff. And one of the best things is we have a quality channel where they can ask quality questions. And I love when a question gets asked and no one on my team has to answer it because someone else answers it,

Meg Sinclair: 

that has to be a beautiful thing when that happens. And so speaking of that that tool, how can we build an environment where employees openly share information, how did you guys facilitate that in your own organizations?

Devon Campbell: 

I think, I'll jump in first. Sorry. I'll reiterate a theme that we touched on earlier, but that's, I think the leadership team needs to openly share information, right? They need. Walk the walk and talk the talk. I know it's cliche, but if they don't, then the example will not be set for the rest of the employees to see that this is the safe place for me to be able to share ideas. And maybe they might be ways that we do things differently than we're doing it right now. You know Those should be openly encouraged as opposed to No, just yes. Just saying yes to everything and moving along through it. So I definitely think to build that environment where all the employees feel open and safe and free to share information and ideas and suggestions, it has to be demonstrated, not just lip service, where we just talking about it, but it needs to be shown by the leadership team. In an open environment. I I mean even Even if, one leader is going one direction and another leader says let's think about this. And let's think through the risk management of it or whatever, in a way that's transparent to the rest of the team, they can see, or that's a safe space where I can explore alternatives and think through what's the risk. What's the impact of patients. What's the impact of the business, all the kind of quality aspects of it. Definitely has to come be demonstrated through the senior year.

Laura Araujo: 

I agree, you know we follow the, celebrate successes, learn from mistakes, but make the learning a really positive one. So that, it's okay to make mistakes. Everybody makes mistakes, it's how you address it and how you learn from it. And so I think that's really important that everybody feels okay to make a mistake it's going to happen. And that really comes down from senior management. I agree, Devin, No blaming no, pointing the finger, it's how do we deal with it? Let's learn from this. Let's never do it again, everybody,

Devon Campbell: 

and the spirit of continuous improvement, you can't make an improvement if you don't make mistakes.

Laura Araujo: 

True. That's true.

Meg Sinclair: 

Yeah. I wonder if maybe instead of mistakes, we just call them opportunities for improvement. We a nice way to think of that. All right. That was some great thoughts on communication and quality. Talk now about data driven decision making and how that impacts quality. Quality needs to be driven by the process and the process must be driven by data. Oftentimes people want to skip a true diagnosis and get to that quick fix. So again, another. Theme I heard from my team today was doing things right. The first time is quality. So Laura, anything you want to share here? Around data driven or in any examples you'd like to share?

Laura Araujo: 

Yeah. So we're a little bit different in that we don't, we don't have sampling and we don't have inspection results or manufacturing, widgets, or lots. And so really what we look at is continuous improvement opportunities, particularly through our quality system. And, there's so much opportunity there in terms of audits, in terms of, just looking at your procedures, how many, how often do your procedures change over time? If they're changing a lot. Maybe it's time to look at the process as a whole. And so we do a lot more of looking at procedural or just opportunities for doing things differently. As opposed to, numbers and data, we don't have a lot of that. But for sure, it's really about making decisions based on what we can see in front of us, not, what you think you might do or what a regulator thinks you should do,

Meg Sinclair: 

or a hunch. Yeah. It's nice to follow the data, Christie or Devin, anything to add here on using data to make your decisions to drive quality.

Devon Campbell: 

I'll jump in Kristen. I'll jump in. And there's even an audience question right now in the chat that's touches on this. It'd be interesting with the rest of the group to look at it. The colleagues think that quality means a lot of data in w. How do we change this mentality? And one thing I will offer up to the group, and then we can maybe chew on it a little bit as a team the cost of for quality, right? We haven't really explored that yet in the call, but if we're not taking credit for the good work that we're doing early, which feels like, oh, it's creating a whole bunch more data. It's really, in most cases, Quality is being done. Savvy engineers and scientists are doing the right thing. Maybe just not documenting or capturing it in a place where that data is being captured, but it's not like things are being done just on a whim. You often think through what are the impacts of this change? What are the impacts of this design? How does this affect enzymes in my app? Good scientists and engineers think through this and in the medical device space, but we don't always necessarily take credit for it that the cost of that poor quality of not taking a moment, just to write it down and think through our rationale or document some of the data that we just did in an indelible way that someone can trust later and look at when you get down the line and you say, oh, wait a second. Now it's time for us to do verification validation. Or now we're going to show some data with the FDA and a precept. And you want to pull that data back. If you haven't really documented it, you can't do hand-waving and say, oh yeah, we did that two years ago. And you pull up some random PowerPoint presentation that you have the data archived on your computer, that's not valid. So you say you want to go back and say, okay I see that you did that, but did you do that test under protocol? Can you repeat that result? How can I trust that? It's that it's accurate. And then you can do it. So a lot of times it's not really that you're creating extra data and double the work it's at some point you're going to have to write it down. And I would argue that you're doubling the work by waiting to the last minute to do it, because now you have to repeat those tests in a way that you can take credit for as opposed to yeah. Actually I've recorded it really early. And I got the data and I dropped it into our quality system and it's there as a quality record. We can go back and reference it if we want to. You did that right from this. As you're growing, it saves you so much more time and money and effort and headache and heartbreak toward the end of the process. When you realize you've done so little of the work that you were supposed to have done. So I think maybe that's one of the, one of the ways to explore changing that mentality is as look at the cost of poor quality curves. It's almost an exponential rate when you get closer and closer to launch and closer to talking to real regular.

Kelly Stanton: 

I have a story that comes out of what you've just described early development process, a very simple process as part of a manufacturing activity. An assumption was made about, we always do it a certain way. That process got acquired by another company. The engineers on the new company made an assumption. Nobody checked the notes, turns out. When we were in the middle of executing, the largest recall the company had ever seen nobody documented the reason for that assumption clear back in the early design process. And as it turned out, when we were going through our investigation and double and troubleshooting and all of these things, trying to understand what was happening the failure rate associated with a very simple process and a very simple assumption was like 73. But nobody wrote it down way back when, and it didn't seem important. Those are the kinds of things that you fast forward, whether it's months or years largest recall that company has ever experienced to date was every single device we had put in the field that we had to pull for this one. Very simple. Assumption. And so I think, to answer that question, but to speak speak to, quality culture, data-driven trending, it's not double the work. It feels like it right now. When you're sitting in that room, trying to decide whether or not you're recalling every single device you've ever made and you're scrolling, you're digging through notes and old notebooks and looking at old data and trying to recalculate some things and figure out like, is this real? Is this not real? If you don't have it documented in a way that's solid and not in some PowerPoint on somebody's computer, you can't, it's not available to you to leverage for the future. It's easy to not think about, the future us decisions, but for those of us who've been in QA for a long time, and the old adage of, if you don't write it down, it didn't happen. I'm sure all of us on this call could tell lots of horror stories about industry that you can root. Cause back to somebody didn't think this was important to doctor. And I could tell stories all day of how that's bitten me in my career over the years, somebody else chose not to down. Now I'm trying to recreate it and figure out what the heck's going on. And it happens in processes. It happens in manufacturing. It's a common thing we think. Go ahead, Christie

Christie Johnson: 

with some of our early stage startup teams. They're really early and everyone thinks that their device can get to market in six months or nine months or a year. And things development. A lot of times just takes longer than everyone thinks too. And there's turnover. People retire, people get different jobs. And even just like that turnover can be really damaging if if we didn't take the time at the beginning to, to really take credit for

Kelly Stanton: 

the work that we do.

Laura Araujo: 

I was just going to add to this as like the opportunity Kelly, when you were speaking about quality to be the teachers, I work with a whole bunch of technology disruptors, I'll say, we're innovative in technology in this space. A lot of people think that, quality and innovation can't live together. They can't say both in the same sentence. And so it's really about me showing that absolutely they can, and giving examples and walking them through and showing people, what we're trying to do is just help in the long run. And here's how, with real examples, with real stories and show them that it's not hard. And we always talk about the real, why, why are you doing this? They go well that, that EMA auditor, I'm like, no, that's not why you're doing it. That might be something that happened that they may, they asked about because you didn't do it, but that's not the real why. So I think that's important too, is for people to understand the real, why, it's not to satisfy a regular later or, even as a, me as a peer quality, it's just because it's the right thing to do. It helps you do your job.

Meg Sinclair: 

Great insights on using data. Thank you. Thank you all. I think data is also great when you don't know where to go, maybe in an investigation and or problem, or with a problem or where to take our process. I think data can really lead you in the right direction. So rather than a hunch following that data. Good great points everybody. Thank you. Let's talk now about our last tool in our toolbox. Oh, I guess we already hit on this panelist question. So I think you had a great talk there. So quality culture is a continuous improvement culture. So getting to using all that data and driving that improvement as we grow and scale our businesses. So I think we hit on this at the beginning, but preventive actions, are we taking those opportunities for improvement and running with it? When we see them and then encouraging feedback and then internal audits are more than just a check box. So let's hit on the first option, that preventative actions. How do you guys use preventative actions to get ahead or get credit for doing the good work you're doing? I know when we have internal audits and have opportunities for improvement or any kind of supplier audits we get, I always like to take those findings, those opportunities for improvement, those suggestions, and turn it into preventative actions and take credit for doing good work and proactive work and being proactive with our system. And then encouraging. Go ahead, Christie.

Christie Johnson: 

I would argue that a preventive action too is for again, for our early stage startups that are really just getting their legs underneath them. I think it's preventive to put in place an early quality system. That's really easy to follow. Maybe not even compliant yet with the standard or the regulation. And I would say it's preventive in a way that it doesn't like super

Meg Sinclair: 

saturate. The people

Laura Araujo: 

who.

Christie Johnson: 

Going to train, use those procedures and turn them off from the beginning. I think baby, stepping an organization into a little bit of structure can be preventive in that it just gives them a little bit of taste to understand a little bit at a time, and then you can revise things

Kelly Stanton: 

and ended document

Christie Johnson: 

every week if you want, or every month, if you want, as the organization grows and becomes more mature.

Kelly Stanton: 

Well I like to Devin was saying earlier about, the development engineers, the scientists involved they're doing good work. And so getting credit for doing that good work by documenting it through. The preventive action process. The auditors love to see that we're using our quality systems. And so I always hate to pull out you should do this because the auditors like it. But as you're building that culture of quality, it comes back to let's take credit for the great work we're doing and these ideas that you have, and maybe how we thought about how this might improve our products or our processes. And maybe we can't do it right now, but if you're at least capturing those ideas, then as things start to build momentum, you can come back to that. And if you haven't and this goes to the feedback, a comment here as well. If you haven't been capturing those things, it's hard to. It's hard to figure out where to start as you're going through and trying to grow it and improve it. And it's really empowering to people to feel like they're being heard and having an idea, feedback going into, the various management teams. We all look at that and go, yeah, this is a great idea. Let's do it. We capture that and take credit for it as a preventive action. That's talk about engagement. That's a great way for people to engage with the systems in place, the quality systems in particular. I think that

Meg Sinclair: 

continuous feedback. With customers and within your organization is an important part of of driving that continuous improvement with your quality. When you're creating that space for people to feel safe, to provide feedback, to improve processes that they're working on, maybe their managers aren't on the frontline, but they are, and they have some insight on what could be improved. I think if you have a good quality culture where you can have space safe spaces for those people to bring up that feedback and improve those processes, that'd be. Demond something to add there.

Devon Campbell: 

Yeah. So I want to, I'm going to touch a live wire here for a second and we'll see how you all respond. Okay. The first check mark here, preventive actions. That's 50% of a four letter word that most people hate to hear in medical devices. A lot of times some people say Kappa people's like shivers, go up their spots. And people are like, oh God, I hate campus systems. And I'm from the development environment. I'm a development person that you mean to do good development in medical devices. You have to be really good at quality, but in the development spheres, particularly you hear a Kappa and you might think, oh God, I worked somewhere else. And once, once you open a Kappa, now everything is just bureaucratic and it takes forever and to do things. So I just want to harp on this for a second. That when we say preventative action, And encouraging feedback and writing things down. We don't necessarily need to do it, especially for earlier companies that aren't as mature yet to have that kind of infrastructure effectively working and in place. What's important is the spirit of it, that we are taking some time to capture it. Maybe it's not in a capita. And I know we only have two of the four letters here, but maybe it's not through that kind of structured meant infrastructure, but to go through and say we should take a good hard look at ourselves on a regular basis and say, how are we doing? What have we done that missed the mark in the last period of time? And how can we do a better job with that going forward? That's really good product. To sit on our, on a regular basis and stop and look back at yourself. Not because the quality system tells you to do it because you're, but because your product development professionals and you want to stop and encourage feedback and reflect on what you're doing, and that's the true spirit of continuous improvement, stopping the applause and look back. It doesn't have to be in a C a P a, a template, but the fact that you go through that exercise and maybe you write it right. At least for an earlier stage company, you write it down and say, Hey, we looked back, we saw a few things where we missed the mark. We're going to do a little bit better this time. Here's how, what we want to try to do. But almost like a like in software development using, like agile sprints, right at the end of each sprint, you stop and you look back and you say, how did we do in that sprint? And what can we do better on the next one on a very regular basis. That's really the true heart of continuous improvement. And I just want, I'm responding here in a live wire way, because we've got two other four letters there that sometimes bristles people's the hair on the back of their necks, curious what the rest of the group thinks.

Laura Araujo: 

I think Kappas are a necessary evil in our world. But I don't think, process improvement should be lumped under the capital world. I think Kappa is a great way to record. Corrective actions that you've taken and root cause of certain issues. But I wanna tell a little story about process improvement. If you guys will humor me for two minutes. I use, I ran my own consulting firm before I joined 4g and I was working with a software development group as a matter of fact, Devin. And they were having trouble getting their documentation done. And they were saying, this is ridiculous. There's too much documentation. We can't do it. We just want to be developers. And so I brought the whole team into a conference room and I had them write down on the walls, around the room, all the documentation that they had to deliver. And then I had them rank them in how easy it was to create those documents. And then I had them rank them on how useful those documents were. And guess what the documents that were hardest to create and maintain were the ones that were of little value to them. I'm like, why are you guys doing. And they're like because the regular I'm like nobody says what type of documents yet. Get rid of it. And they're like, we can do that. I'm like, you can do that. So I think that's the thing, I hate to keep harping on quality as the teachers, but that's what we have to do. We have to lead them through sometimes to show them, because either in their careers or people they've met or regulators, there were bad regulators out there, there are bad inspectors. And that sticks with people, when they become fearful and we just have to make them realize that's not all there is to this.

Meg Sinclair: 

Speaking next to audits and auditors. I think another sign of a continuous improvement culture is feeling like internal audits are more than just a checkbox. I feel like a lot of organizations see them as just a requirement to fulfill every year. But if you can really embrace internal audits and reflect on those changes, you need to make, you can really go above and beyond and improve your quality culture. I know I have an internal audit coming up myself next week, and I'm quite excited to have some fresh eyes on my sister. And that a similar sentiment for you guys

Laura Araujo: 

that Meg is trust. So our internal audits I think, are really successful because I and my team have shown that we're never going to share those with anybody. Internal audits are strict. For process improvement. We don't share them with our clients. We don't, we share results for continuous improvement, but we want them to be uh, feel free to say anything to us, so that we can help them. And so I think that getting to that point is really where you should be instead of fearing that your auditors are either checking boxes or looking for issues like I'm gonna catch you, not following your process. It's that's not the purpose of an audit. Yeah.

Christie Johnson: 

I think that gotcha. Mentality is something that a lot of quality professionals fall into where they become like Lauren, you were saying at the beginning, like the police were oh, there's an internal audit today. Everybody clean up your desk and don't say the wrong thing and yeah. I think that's also top management's job is to set the expectation that in the setting of an internal audit, there should be conversations and a room for employees to provide, not just provide real feedback about improving processes, but also for the quality team to sit down, pull the process, sit down with an employee and say, okay, here's what's required in the regulation or the standard or whatever the target is. But we have some leeway in here, help me craft what this actual procedure says, what would work for you and just giving, inviting your team in to participate in a way that's more of encouraging them to own part of the process and really weigh in. And then they're more likely to want to

Kelly Stanton: 

follow it too.

Devon Campbell: 

I like a piece of that Christie that you said. Anger me when people would say, oh, I have to do something or I can't do something because the regulations say so. And I've been in the industry long enough that I used to carry around a little blue book in my pocket and I'd say, okay, show me where eight 20 says that. And I'd call BS and, people hide behind. In a lot of times, people in the quality of laboratory space will hide behind the processes of the company and say we have to do this because regulators say it and scare people into doing it. And I'd pull it back out and say no, the regulation doesn't say that. And I liked what you were saying there, Christie if the rest of the organization and the team and the people that are following particular process, Yes. They understand the process that you're following is something that company has written. And, you've established a process. You need to demonstrate that you're following the process and you have objective evidence to suggest that, to show that you're doing it, but it's not necessarily that the regulations say you have to. Do things in a super specific way. I think if people, no, it, they might be more prone to help challenge status quo and say, why are we doing this in this SOP? They might be more open to challenging it because they know it's really our interpretation of what the regulation says. Maybe we can do it better and still meet the spirit of the regulation as opposed to, I can't challenge this. This is just what we have to do to meet the regulation. Of course, there are things that, are black and white like that, but I would say probably 90% of the time, it's not, it's really the company's interpretation of, and the SOP says they've written in the work instructions they've written that really shouldn't be challenged.

Christie Johnson: 

I think it's a responsibility too, of management and anyone working in quality to running an audit to get to know. If you're in charge of quality for an organization, get to know the people who are executing the procedures, learn their backgrounds, where what's their training, what's their focus, where are their strengths and what things are going to definitely be opportunities for improvement and help craft the language that is written in a way that they'll be able to understand and execute.

Kelly Stanton: 

Yeah, I think we can fall into the trap of, and by we, quality professionals can fall into that trap of being your own worst enemy. And not being approachable, not being collaborative. And that kind of culture can definitely come from, can start from the top or it can start at an individual contributor level. But, if everybody's trying to do the right thing and I don't think people are ever trying to do the wrong thing. I think there's just, there can be gaps in processes and gaps in understanding and, All of continuous improvement is about addressing those gaps. I think Laura said it best at the, earlier we're all human people make mistakes. If those mistakes are going to result in, a faulty products or process not followed and therefore a regulatory risk, how do we make sure that everyone can. Feel safe to come forward when they see those kinds of things contribute to overall quality. And there was a comment from an audience member about, organizations develop an audit culture rather than a quality culture focuses more on policies and procedures, not a lived culture. That's absolutely. The wrong way to go about a quality culture audits should be a tool, but it should be a very open, transparent, collaborative conversation where everybody, again, we come back to everybody understands how, what they do contributes to that overall. Cultural approach. And, when you get into those, because I've done the same thing, Devin. Yeah. Okay. I appreciate your feedback. Show me in the regulations where it says we have to do this, and that can be a good fallback. That can also be a bad fallback, but it, but if you can continue the conversation in those moments there may be amazing new ideas and ways to do it differently that are still compliant. But if we don't encourage feedback, react to that, engage lots of people in the quality culture as a whole. Then everybody's just going to sit in their little cube and do their job and not speak up and contribute to those that whole thing. And that takes quality culture down in a hurry. Yeah,

Devon Campbell: 

real fast

Laura Araujo: 

and auditor's can't yeah, just be auditors, right? They can't just breeze in and audit and breeze out. They gotta be involved in the organization and, you have audit plans for a reason because plans can change. And if there's an opportunity to do some big learning versus, finishing an audit, I'm going to do the learning thing, and my audit plan can change. It's a plan. I think that's really important. Auditors have to be part of the whole, not this independent group that comes in like a regulator,

Meg Sinclair: 

And I think if you have a healthy quality culture in place, you'll be ready for whatever audit comes and you'll have all the things and people will be living and breathing that quality system and those policies. And then there won't need to be that audit culture. So just to tack onto that so we've talked a lot about a lot of tools that we're all using for continuous improvement. Are there any that we didn't talk about here, panelists that you wanted to highlight for our

Laura Araujo: 

listeners? I just want to bring up one thing that we touched on, but we haven't said a lot about it and that's really. If you look at every regulation today, every guidance document that's comes out, they all talk about risk and taking risk into account. That being said, regularly, even regulators know we have to run businesses. And so it's really about risk, bite off small pieces. What are the riskiest areas you need to focus on first? You don't have to do everything perfectly the first time. Yeah. You just do it based on risk, look at your highest areas of risk. What are the things that, where are you going to get the biggest bang for your buck? The low hanging fruit, all those sort of words we use to explain it. I think that's really important for us to identify risk and use risk as a tool to drive our continuous improvement.

Kelly Stanton: 

Right.

Meg Sinclair: 

So just to review. A quality culture is about seeing, hearing and feeling that quality all around you. It's everyone's responsibility. It's personalizing those outcomes to quality behaviors to create a high impact for frontline workers and top management. Quality is going to be driven by processes. And those processes must be driven by data and then take credit for improving the quality culture and celebrate those victories in public ways. Whether that's management review in your channels and your communication channels, just be really deliberate in celebrating those quality victories.